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JKM > Volume 35(3); 2014 > Article
Eom: Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act



There is an issue in applying various principles introduced in established Korean medical classics to “Pharmaceuticals Approval, Notification and Review” of “herbal medicinal preparations” and “new drugs from natural products” that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential.


We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects.


Established Korean medical classics are applied as follows:
  1. as criteria for Korean medicine distributors’ sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953),

  2. as official compendiums for pharmacists’ preparation of Korean medicine (Ministry of Health and Welfare’s authoritative interpretation; from early 1970s to 1993),

  3. as standards for oriental pharmacists’ quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995),

  4. as criteria for “Pharmaceuticals Approval, Notification and Review” of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and

  5. as standards for the quality of materials of health functional food (from 2004 to 2011).


The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

Fig. 1.
The Application of Established Korean Medical Classics in Korean Pharmaceutical Affairs Act
Table 1.
The Changes of Provisional Regulations on Established Korean Medicinal Classics
년도 명칭 예규·고시 번호 비고
1969 년 기성 한약서에 대한 잠정 규정 보건사회부예규 233호 한약종상, 11종 한약서
2002년 기성 한약서에 대한 잠정 규정 보건복지부고시 제2002-79호 한약업사, 11종 한약서
2008년 기존 한약서에 대한 잠정 규정 보건복지가족부고시 제2008-175호 한약업사, 10종 한약서
2014년 기존 한약서에 대한 잠정 규정 보건복지부고시 제2014-27호 한약업사, 10종 한약서 제5조(재검토기한) 신설
Table 2.
The Comparison of Categories of Established Korean Medicinal Classics
1969년 6월 7일 1999년 2월 11일 2008년 8월 14일 2008년 12월 31일 2011년 5월 30일
<기성한약서에 대한 잠정규정> <의약품 등의 안전성 유효성 심사에 관한 규정> <의약품 등의 품목허가신고심사 규정> <기존한약서에 대한 잠정규정> <한약(생약)제제 등의 품목허가신고에 관한 규정>
기성한약서 한약서 한약서 기존한약서 한약서
동의보감 동의보감 동의보감 동의보감 동의보감
방약합편 방약합편 방약합편 방약합편 방약합편
향약집성방 향약집성방 향약집성방 향약집성방 향약집성방
경악전서 경악전서 경악전서 경악전서 경악전서
의학입문 의학입문 의학입문 의학입문 의학입문
제중신편 제중신편 제중신편 제중신편 제중신편
광제비급 광제비급 광제비급 광제비급 광제비급
수세보원 수세보원
동의수세보원 동의수세보원 동의수세보원 동의수세보원
본초강목 본초강목 본초강목 본초강목 본초강목
약성가 약성가 약성가
사상의학 사상의학
한약조제지침서 한약조제지침서
Table 3.
Books for National Examination for Medical Practitioners in Joseon Dynasty and Established Korean Medicinal Classics
1486 성종16년 1749 영조24년 1865 고종15년 1969년 대한민국 2008년대한민국 2014년 대한민국
경국대전 속대전 대전회통 보건사회부예규제233호 보건복지가족부고시 제2008-175호 보건복지부고시제2014-27호
본초 본초 본초
직지방 직지방 직지방
동인경 동인경 동인경
찬도맥 찬도맥 찬도맥
동원10서 동원10서
의학정전 의학정전
소문 소문
의학입문 의학입문 의학입문 의학입문
방약합편 방약합편 방약합편
동의보감 동의보감 동의보감
향약집성방 향약집성방 향약집성방
광제비급 광제비급 광제비급
제중신편 제중신편 제중신편
사상의학 동의수세보원 동의수세보원
경악전서 경악전서 경악전서
수세보원 수세보원 수세보원
본초강목 본초강목 본초강목
Table 4.
Periodical Changes of the Function of Pharmacists and Distributors of Korean Medicine
조선 대한제국 일제강점기 건국이후 현재
主簿 藥劑士 藥劑士 약사(1953) 약사
한약사(1994) 한약사
藥商 藥種商(韓藥, 洋藥) 藥種商(서양약) 약종상(1953) 약종상
漢藥種商(한약) 한약종상(1953) → 藥業士(1971) → 韓藥業士(1986) 한약업사


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